Plant making half of U.S. flu vaccine ordered shut / Healthy Americans asked to yield doses to most vulnerable

Sabin Russell, Chronicle Medical Writer

Published
4:00 am PDT, Wednesday, October 6, 2004

Flu Vaccine Manufacturing. Chronicle graphic by John Blanchard

Flu Vaccine Manufacturing. Chronicle graphic by John Blanchard

Photo: John Blanchard

Photo: John Blanchard

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Flu Vaccine Manufacturing. Chronicle graphic by John Blanchard

Flu Vaccine Manufacturing. Chronicle graphic by John Blanchard

Photo: John Blanchard

Plant making half of U.S. flu vaccine ordered shut / Healthy Americans asked to yield doses to most vulnerable

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America's crisis-prone flu-shot program was thrown into chaos Tuesday when the British government abruptly and unexpectedly pulled the license of the Liverpool factory responsible for making half the U.S. flu vaccine supply.

Top U.S. health officials immediately called on Americans to ration voluntarily the nation's remaining 55 million doses -- enough to cover most of those at highest risk but far short of the 87 million vaccinations given last flu season.

Newly revised guidelines put a priority on giving flu shots first to those over the age of 65; persons over the age of 2 with chronic health problems; pregnant women; nursing home residents; and health care workers. Flu shots also are recommended for babies and toddlers ages 6 to 23 months, but they receive special dosages that are not made by Chiron.

On the eve of this year's flu season -- which typically begins in early December but last year started a month early -- the U.S. flu-shot program now is almost entirely reliant on the 54 million doses of vaccine produced by Aventis Pasteur of Swiftwater, Pa. The company already has shipped 30 million doses to its customers.

Another 1.1 million doses of a more expensive, nasally administered flu vaccine have been made by MedImmune of Gaithersburg, Md. Sales of that vaccine, which is made from a live but greatly weakened flu strain, were disappointing last year.

Still, the British action creates an immediate flu-shot shortage. It brought an apology from Chiron Chief Executive Officer Howard Pien. "We profoundly regret that we will be unable to meet the public health needs this influenza season," he said at an Oakland news briefing shortly after conferring with Thompson by telephone.

British regulators said, in effect, that the Chiron plant had failed an inspection of its general manufacturing procedures. The inspection was triggered last month by the company's disclosure in late August that up to 4 million doses of vaccine had been contaminated and had failed a sterility test. As a result of Chiron's discovery, none of its vaccine was released to the public, although millions of doses were awaiting shipment from distributors' warehouses.

Details of the British decision remained unavailable Tuesday, but Chiron characterized them as systemwide concerns rather than a focus on the relatively small number of contaminated lots.

The regulators imposed a three-month suspension of the Liverpool plant's license to make the vaccine.

Pien indicated there was little prospect that British regulators would change their mind or that the vaccine eventually would be declared safe and sold.

"The products will be destroyed in due course," he said.

The Chiron chief called the British action "disappointing and unexpected, " but he refused to criticize the regulators, who have jurisdiction over the plant the company purchased last year as part of its $948 million acquisition of PowderJect Pharmaceuticals.

"We respect their regulatory judgment because it is based on concerns over safety," Pien said.

He added that Chiron will begin discussions today in the United Kingdom on how to alleviate those concerns, and he stressed that the company remains committed to producing a high volume of flu shots for next year.

Pien contends that Chiron scientists had isolated the contamination problem to a human error in one of the last of 12 steps in the flu-shot production process, a problem that was restricted to a small number of lots. Nevertheless, the company has steadfastly refused to identify the nature of the sterility problem or to reveal precisely how it occurred.

For the nation's beleaguered flu-shot program, the latest turn of events could hardly have come at a worse time. Flu-shot season begins in October and typically runs through early December. Mass immunization clinics, already delayed at least two weeks by Chiron's initial setback, had been gearing up for launch next week in anticipation that the U.S. Food and Drug Administration would agree that Chiron's contamination problem had been solved.

The announcement brought back memories of the 2000-2001 flu-shot season, when manufacturers had difficulties making the vaccine and it was in short supply until December. Many healthy Americans were provided flu shots through corporate health programs, while elderly people deemed most vulnerable to influenza could not find the shots.

Since then, the number of flu-shot makers has dwindled to two, yet enhanced production lines were attempting to crank out more vaccine than ever. This year's projected 100 million doses would have topped all previous years, prompting the federal Centers for Disease Control and Prevention to urge anyone over the age of 50 to get a flu shot.

This latest shortage of flu shots underscores the fragility of the vaccine production system, which relies on a mid-20th century technology of growing flu virus in millions of chicken eggs, killing the virus and injecting purified forms of the viral debris into the arm to stimulate protective antibodies.

It also highlights the United States' reliance on a foreign supplier for half the vaccine produced in the annual immunization program, which is designed to reduce the estimated 36,000 deaths caused by influenza each year.

Last year, the 87 million doses of vaccine produced were scooped up because flu season arrived early and caused an unusually high number of deaths -- 152 -- among children under age 18. Ironically, the vaccine was not a perfect match to the prevailing flu strain and was less effective in preventing the illness than in other years.

Chiron's initial problem had appeared to be headed for resolution as early as this week. Distributors say that all the signals pointed to an imminent green light to ship vaccine to their customers. Now, they foresee big headaches.

"You've got a four-lane freeway, and all of the sudden two lanes are closed, and it's rush hour," said Gene Alley, chief executive officer of Stat Pharmaceuticals, a San Diego flu-shot distributor. He said his company's telephone banks are overloaded with calls from customers, who had been expecting to hear that the delay in Chiron shipments was about to end.

"This is the panic we didn't want," he said.

Only two weeks ago, public health officials were upbeat about the impending distribution of flu shots. The federal Centers for Disease Control and Prevention on Sept. 27 stuck to a prediction that 100 million doses of flu vaccine would be available this season and recommended that vaccinations proceed "as soon as vaccine is available."

David Webster, a Lehigh Valley, Pa., health care consultant, said the latest developments are a "black eye" for the CDC.

"They've actively encouraged people to vaccinate healthy adults," he said. "They've reinforced the message that there would be no shortage. They've lost a lot of credibility in the eyes of health care providers."

Scarce supply

Who should be vaccinated? Adults over 65, anyone over 2 with a chronic medical condition, pregnant women, nursing home residents and children ages 6 months to 23 months.

Who should not? Healthy young and middle-aged adults, who are less at risk of death from the flu.

What else can you do?

Take precautions to avoid getting sick: Wash your hands frequently, eat well, and get plenty of exercise and rest. If you fall ill, avoid spreading the bug: Cover your mouth and nose with tissue when you cough, and stay home.

The production of flu vaccine begins more than a year before flu season arrives. Federal health officials studying the flu viruses active in the Southern Hemisphere try to anticipate which viruses will arrive here in the autumn.